Lean Engineer

Beta Bionics, Inc.; Irvine (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical & Dental

HSA/FSA Options

401(k) match

Paid vacation & holidays

Job summary

Beta Bionics, Inc. is seeking a Manufacturing Excellence professional to apply Lean principles on the production floor, performing time studies, standard work, and capacity models. You will partner with cross-functional teams to reduce waste and improve safety, quality, and productivity across operations.

The role emphasizes hands-on training, line audits, and real-time resource allocation, with a focus on implementing improvements and sustaining results in a regulated manufacturing environment.

Qualifications

• Must have strong knowledge of Lean manufacturing and waste elimination.
• Ability to perform time studies, work measurement, line balancing, and labor planning.
• Translate production data into practical, measurable improvements.

Responsibilities

• Conduct time and motion studies; establish cycle times and labor standards.
• Balance production lines and allocate labor across shifts.
• Improve layouts, standard work, visual controls, and ergonomics.
• Perform line audits and track corrective actions.
• Lead Lean improvement activities using value-stream mapping, Kaizen, and 5S.
• Analyze OEE, throughput, downtime, and yield for improvement opportunities.
• Apply Lean Six Sigma methods (DMAIC) to reduce variation and issues.
• Develop training materials; train operators and supervisors on standard work.
• Collaborate with Quality and Engineering on process improvements.
• Maintain project plans and communicate progress to stakeholders.
• Perform additional duties as needed.

Skills

Lean manufacturing

Time studies

Line balancing

Capacity analysis

Labor planning

Data analysis

Problem solving

Cross-functional collaboration

Communication & training

Regulatory awareness

Education

Bachelor's degree in IE/ME/Operations

Lean Six Sigma Green Belt

Tools

Minitab

Power BI

Excel

ERP / MES

Job description

About Beta Bionics

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions – and a better life for those living with diabetes – with the world’s first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user’s weight – the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management.
*User must be carb aware.

Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact.

Summary/Objective

Responsible for applying Lean manufacturing principles and data-driven methods to improve safety, quality, delivery, cost, and productivity across manufacturing operations. Performs time studies, establishes standard work, balances production lines, and develops staffing and capacity models.
Works directly on the production floor with cross-functional teams to identify waste, address constraints, support real-time resource allocation, conduct line audits, implement improvements, and train employees to sustain results.

Essential Duties and Responsibilities

[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company’s HR contact]

• Conduct time and motion studies to establish accurate cycle times, takt-time requirements, labor standards, and production capacity.
• Analyze work content, demand, staffing, and constraints to balance production lines; monitor real-time output, work-in-process, downtime, attendance, and bottlenecks; and partner with production leaders to relocate labor and resources based on business priorities.
• Develop and improve line layouts, workstation configurations, standardized work, visual controls, and ergonomic methods to reduce waste and improve operator effectiveness.
• Conduct routine line audits focused on standardized work, 5S, staffing, material flow, productivity, and process discipline; document findings and track corrective actions to closure.
• Lead or support Lean improvement activities using tools such as value-stream mapping, Kaizen, 5S, waste analysis, standard work, visual management, and setup reduction.
• Analyze cycle time, throughput, labor efficiency, yield, scrap, downtime, and Overall Equipment Effectiveness (OEE) to identify trends and improvement opportunities.
• Apply Lean Six Sigma methods, including DMAIC, root cause analysis, and statistical analysis, to resolve recurring issues and reduce variation.
• Develop training materials and provide hands-on training and coaching to operators, leads, supervisors, and support personnel on standard work, Lean tools, and new processes; verify training effectiveness and sustained adoption.
• Partner with Quality and Engineering to assess, document, approve, and implement improvements in accordance with the Quality Management System; support new product introductions, ramp-up, and process transfers.
• Maintain project plans, action logs, and benefit tracking, and communicate progress, risks, and results to stakeholders and management.
• Perform other duties as assigned.

Required Education and Experience

Knowledge, Skills & Abilities

• Strong knowledge of Lean manufacturing principles, waste elimination, continuous improvement, and production flow.
• Demonstrated ability to perform time studies, work measurement, line balancing, capacity analysis, and labor planning
• Ability to translate production data and floor observations into practical, measurable improvements.
• Strong analytical, root cause analysis, statistical, project-management, and problem-solving skills.
• Effective communication, training, facilitation, coaching, change-management, and cross-functional collaboration skills.
• Working knowledge of quality systems and regulatory requirements in a regulated manufacturing environment.
• Proficiency in Microsoft Excel and data-analysis tools; experience with Minitab, Power BI, ERP, or Manufacturing Execution Systems is preferred.
• Ability to work independently, maintain a strong production-floor presence, and adapt to changing production demands.

Minimum Certifications / Educational Level

• Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Operations, or a related field, or an equivalent combination of education and relevant experience.
• Lean Six Sigma certification, preferably Green Belt or higher, is preferred.

Minimum Experience

• 3-5 years of experience in manufacturing engineering, industrial engineering, operational excellence, or continuous improvement, preferably in the medical device or another regulated industry.
• Hands-on experience conducting time studies, balancing production lines, developing staffing models, and implementing standardized work.
• Experience applying Lean and Six Sigma methods to measurable improvement projects and training or facilitating teams is preferred.
• Experience with FDA, ISO 13485, GMP, or similar quality-system requirements is preferred.

Work Schedule

• Full-time, onsite position with regular presence on the manufacturing floor.
• Must be able to adjust the schedule to support multiple shifts, time studies, audits, training, and improvement implementation; occasional overtime, weekend work, or off-shift coverage may be required.

Work Environment and Personal Protective Equipment

• Works in office, production, laboratory, clean room, and warehouse environments. Personal Protective Equipment may be required for production-floor, laboratory, clean-room, or field work.

Physical Demands

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
• This position requires travel up to 5% depending upon business needs.

Salary Range

$90,000 - $125,000

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.